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Gip/Glp1 Agonist Compositions - EP3810201

The patent EP3810201 was granted to ELI Lilly on Aug 2, 2023. The application was originally filed on Jun 14, 2019 under application number EP19739766A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3810201

ELI LILLY
Application Number
EP19739766A
Filing Date
Jun 14, 2019
Status
Granted And Under Opposition
May 5, 2023
Grant Date
Aug 2, 2023
External Links
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Patent Oppositions (7)

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BULLE DRMar 7, 2024KUTZENBERGER WOLFF & PARTNERADMISSIBLE
GALENICUM HEALTH SLUMar 7, 2024GALENICUM HEALTH SLUADMISSIBLE
GENERICS UKMar 7, 2024ELKINGTON AND FIFEADMISSIBLE
ELKINGTON AND FIFEMar 6, 2024ELKINGTON AND FIFEADMISSIBLE
STRAWMANMar 6, 2024HOFFMANN EITLEADMISSIBLE
KRAUS & LEDERER PARTGMBBMar 5, 2024KRAUS & LEDERER PARTGMBBADMISSIBLE
SANDOZFeb 23, 2024TER MEER STEINMEISTER & PARTNERADMISSIBLE

Patent Citations (28) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

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Non-Patent Literature (NPL) Citations (55) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
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OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION TRESIBA (insulin degludec injection), for subcutaneous use", HIGHLIGHTS OF PRESCRIBING INFORMATION TRESIBA, FDA, US, US, (20180301), pages 1 - 57, HIGHLIGHTS OF PRESCRIBING INFORMATION TRESIBA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf, XP093230425-
OPPOSITION- Anonymous, "OZEMPIC (semaglutide) injection, for subcutaneous use", (20171201), pages 1 - 44, OZEMPIC HIGHLIGHTS OF PRESCRIBING INFORMATION, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf, (20240610), XP093171358-
OPPOSITION- Anonymous, "OZEMPIC (semaglutide) injection, for subcutaneous use", OZEMPIC HIGHLIGHTS OF PRESCRIBING INFORMATION, FDA - Food and Drug Adminstration, (20171201), pages 1 - 44, OZEMPIC HIGHLIGHTS OF PRESCRIBING INFORMATION, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf, XP093171358-
OPPOSITION- Anonymous, "PRESCRIBING INFORMATION. MOUNJARO TM (tirzepatide) Injection, for subcutaneous use Initial U.S. Approval: 2022", FDA, (20220501), XP093086105-
OPPOSITION- Anonymous, "Saline (medicine)", Wikipedia, (20240128), pages 1 - 9, Wikipedia, URL: https://en.wikipedia.org/w/index.php?title=Saline_(medicine)&oldid=1200029006, XP093174307-
OPPOSITION- Anonymous, "SAXENDA (liraglutide frDNA origin] injection), solution for subcutaneous use", SAXENDA HIGHLIGHTS OF PRESCRIBING INFORMATION, (20140101), pages 1 - 40, XP093172515-
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OPPOSITION- Barry S. Selinsky, Membrane Protein Protocols - Expression, Purification and Characterization, Humana Press, Inc., (20030101), page 241, XP093169933-
OPPOSITION- B. Braun Medical Inc. , "SODIUM CHLORIDE- sodium chloride injection, solution ", FDA Label NDA 19635/S-035, FDA, (20140101), pages 1 - 7, FDA Label NDA 19635/S-035 , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf, XP093174348-
OPPOSITION- Broadhead J, Gibson, M, "Chapter 9: Parenteral Dosage Forms (passage)", Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, CRC Press, (20090101), vol. 199, pages 325 - 328, XP055882149-
OPPOSITION- Broadhead Joanne , Mark Gibson, "Parenteral Dosage Forms", Broadhead Joanne , Mark Gibson, Mark Gibson, Pharmaceutical Preformulation and Formulation, Second Edition, Informa Healthcare, (20090101), pages 329 - 329, ISBN 978-1-4200-7317-1, XP093322875-
OPPOSITION- Chandra Mohan, "Buffers - A guide for the preparation and use of buffers in biological systems", Buffers, EMD, (20060101), pages 1 - 38, Buffers, URL: https://www.med.unc.edu/pharm/sondeklab/wp-content/uploads/sites/868/2018/10/buffers_calbiochem.pdf, XP093166857-
OPPOSITION- Eli Lilly And Company, "A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)", ClinicalTrials.gov, NLM, (20170628), pages 1 - 12, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT02759107?cond=NCT02759107&rank=1&tab=history&a=12#version-content-panel, XP093174364-
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OPPOSITION- Medicago Ab, "Smartbuffers - Phosphate Buffered Saline (PBS), ph 7,4 and 7,2", Smartbuffers, Medicago AB, (20100906), Smartbuffers, URL: http://www.medicago.se/sites/default/files/pdf/productsheets/PBS_Buffer_v._01.pdf, (20170811), XP055398326-
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OPPOSITION- Rowe Raymond C, Sheskey Paul J, Quinn Marian E, "Sodium Chloride", Handbook of Pharmaceutical Excipients, 6th ed., (20090101), pages 637 - 639, XP093172252-
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OPPOSITION- RUDOLF VOIGT, MANFRED BORNSCHEIN, "19.5.4. Isohydrische Lösungen", RUDOLF VOIGT, MANFRED BORNSCHEIN, Rudolf Voigt, Lehrbuch der pharmazeutischen Technologie, WEINHEIM , VERLAG CHEMIE , (19840101), pages 394 - 395, ISBN 3-527-26112-5, XP009558574-
OPPOSITION- "Sodium Chloride", Rowe Raymond C, Sheskey Paul J, Quinn Marian E, Handbook of Pharmaceutical Excipients, 6th ed., (20090101), pages 637 - 639, XP093172252-
OPPOSITION- Sven Frokjaer, Pharmaceutical Formulation Development of Peptides and Proteins, (20000101), pages 124, 125, 150, 151, 188 - 191, XP093169936-
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OPPOSITION- Yu Minzhi; Benjamin Mason M.; Srinivasan Santhanakrishnan; Morin Emily E.; Shishatskaya Ekaterina I.; Schwendeman Steven P.; Schwendeman Anna, "Battle of GLP-1 delivery technologies", Advanced Drug Delivery Reviews, Elsevier, Amsterdam , NL, Amsterdam , NL , (20180721), vol. 130, doi:10.1016/j.addr.2018.07.009, ISSN 0169-409X, pages 113 - 130, XP085451322
OPPOSITION- Coskun Tamer, Sloop Kyle W; Loghin Corina; Alsina-Fernandez Jorge; Urva Shweta; Bokvist Krister B; Cui Xuewei; Briere Daniel A; Cabrera Over; Roell William C; Kuchibhotla Uma; Moyers Julie S; Benson Charles T; Gimeno Ruth E; D'alessio David A; Haupt Axel, "SUPPLEMENTAL APPENDIX: LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept", Molecular Metabolism, (20181201), vol. 18, doi:10.1016/j.molmet.2018.09.009, ISSN 2212-8778, pages 1 - 28, XP093174577
OPPOSITION- Tamer Coskun, Sloop Kyle W., Loghin Corina, Alsina-Fernandez Jorge, Urva Shweta, Bokvist Krister B., Cui Xuewei, Briere Daniel A., Cabrera Over, Roell William C., Kuchibhotla Uma, Moyers Julie S., Benson Charles T., Gimeno Ruth E., D'alessio David A., Haupt Axel, "LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept", Molecular Metabolism, (20181201), vol. 18, doi:10.1016/j.molmet.2018.09.009, ISSN 2212-8778, pages 3 - 14, XP055567725
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OPPOSITION- Pia K. Norregaard, Deryabina Maria A., Tofteng Shelton Pernille, Fog Jacob U., Daugaard Jens R., Eriksson Per‐olof, Larsen Lone F., Jessen Lene, "A novel GIP analogue, ZP4165, enhances glucagon-like peptide-1-induced body weight loss and improves glycaemic control in rodents", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20180108), vol. 20, no. 1, doi:10.1111/dom.13034, ISSN 1462-8902, pages 60 - 68, XP055568531
OPPOSITION- Torben Laursen; Birtha Hansen; Sanne Fisker, "Pain Perception after Subcutaneous Injections of Media Containing Different Buffers", Basic & Clinical pharmacology & toxicology, Copenhagen , DK, (20060130), vol. 98, no. 2, doi:10.1111/j.1742-7843.2006.pto_271.x, ISSN 1742-7835, pages 218 - 221, XP072369567
OPPOSITION- Torben Laursen; Birtha Hansen; Sanne Fisker, "Pain Perception after Subcutaneous Injections of Media Containing Different Buffers", BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, NORDIC PHARMACOLOGICAL SOCIETY, COPENHAGEN, DK, COPENHAGEN, DK , (20060130), vol. 98, no. 2, doi:10.1111/j.1742-7843.2006.pto_271.x, ISSN 1742-7835, pages 218 - 221, XP072369567
OPPOSITION- J. Fransson, Espander-Jansson A., "Local Tolerance of Subcutaneous Injections", Journal of pharmacy and pharmacology : JPP, John Wiley & Sons Ltd, London, GB, GB , (19961116), vol. 48, no. 10, doi:10.1111/j.2042-7158.1996.tb05892.x, ISSN 0022-3573, pages 1012 - 1015, XP055364940
OPPOSITION- J. Fransson, Espander-Jansson A., "Local Tolerance of Subcutaneous Injections", J. Pharm. Pharmacol., (19961116), vol. 48, doi:10.1111/j.2042-7158.1996.tb05892.x, pages 1012 - 1015, XP055364940
OPPOSITION- Joseph R.Chabenne, Maria A.DiMarchi, Vasily M.Gelfanov and Richard D.DiMarchi, "Optimization of the Native Glucagon Sequence for Medicinal Purposes", Journal of Diabetes Science and Technology, Diabetes Technology Society, US, US , (20101101), vol. 4, no. 6, doi:10.1177/193229681000400605, ISSN 1932-2968, pages 1322 - 1331, XP007920819
OPPOSITION- Akturk Halis Kaan, Dong Fran, Snell-Bergeon Janet K., Karakus Kagan Ege, Shah Viral N., "Efficacy and Safety of Tirzepatide in Adults With Type 1 Diabetes: A Proof of Concept Observational Study", Journal of Diabetes Science and Technology, Diabetes Technology Society, US, US , (20240205), doi:10.1177/19322968231223991, ISSN 1932-2968, pages 1 - 5, XP093230459
OPPOSITION- So Jineon, "Improving Patient Compliance with Biopharmaceuticals by Reducing Injection-Associated Pain", Journal of mucopolysaccharidosis and rare disease, (20150630), vol. 1, no. 1, doi:10.19125/jmrd.2015.1.1.15, ISSN 2465-8936, pages 15 - 18, XP093175502
OPPOSITION- Philip J. Larsen, Christian Fledelius, Lotte Bjerre Knudsen, and Mads Tang-Christensen, "Systemic Administration of the Long-Acting GLP-1 Derivative NN2211 Induces Lasting and Reversible Weight Loss in Both Normal and Obese Rats", Diabetes, American Diabetes Association :, (20010101), vol. 50, doi:10.2337/diabetes.50.11.2530, ISSN 0012-1797, pages 2530 - 2539, XP007912464

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